Tobacco chewing gum formulation

Abstract

A chewing gum formulation including tobacco particles and a gum base, where the gum base includes one or more hydrophobic gum base polymers, and where the tobacco particles are made from tobacco leaves. The amount of tobacco particles is between 0.5 and 30% by weight of the chewing gum formulation, and nicotine is released from the tobacco particles when chewing the chewing gum formulation.

Claims

1. Chewing gum formulation comprising tobacco particles and a gum base, wherein the tobacco particles have a nicotine content and comprises tobacco fibers, and wherein the gum base comprises one or more hydrophobic gum base polymers, and wherein the tobacco particles are made from tobacco leaves, wherein the amount of tobacco particles is between 0.5 and 30% by weight of the chewing gum formulation, wherein at least 40% by weight of tobacco fibres comprised in the tobacco particles are retained in the chewing gum formulation after the chewing gum formulation has been chewed in vitro in accordance with European Pharmacopeia 6th. ed. 2.9.25 in a pH 7.4 phosphate buffer for 10 minutes, and wherein more than 55% of the nicotine content in the chewing gum formulation is released from the chewing gum formulation, after the chewing gum formulation has been chewed in vitro in accordance with European Pharmacopeia 6th. ed. 2.9.25 in a pH 7.4 phosphate buffer for 10 minutes.

2. Chewing gum formulation according to claim 1, wherein the amount of tobacco particles is between 3-15% by weight of the chewing gum formulation.

3. Chewing gum formulation according to claim 1, wherein the amount of nicotine in the tobacco particles is between 0.2-4% by weight of the tobacco particles.

4. Chewing gum formulation according to claim 1, wherein the ratio by weight between gum base and tobacco particles is between 25:1 and 2:1, and wherein the chewing gum formulation further comprises buffer.

5. Chewing gum formulation according to claim 1, wherein the tobacco particles have been mixed into the gum base, whereby a moderated release of nicotine from the chewing gum formulation is obtained.

6. Chewing gum formulation according to claim 1, wherein at least 50% by weight of the tobacco particles have a size below 700 m.

7. Chewing gum formulation according to claim 1, wherein the amount of tobacco particles is between 0.5-10% by weight of the chewing gum formulation, wherein the amount of gum base is between 20 and 90% by weight of the chewing gum formulation and wherein the chewing gum formulation comprises a buffer.

8. Chewing gum formulation according to claim 1, wherein the chewing gum formulation comprises buffer in an amount of 0.1% to 10% by weight of the chewing gum.

9. Chewing gum formulation according to claim 1, wherein the chewing gum formulation comprises buffer in an amount of less than 5% by weight of the chewing gum.

10. Chewing gum formulation according to claim 1, wherein the chewing gum formulation is substantially free of buffer.

11. Chewing gum formulation according to claim 1, wherein the buffer is selected from the group consisting of sodium carbonate, sodium hydrogen carbonate, potassium carbonate, potassium hydrogen carbonate, dipotassium phosphate, potassium citrate, or any combination thereof.

12. Chewing gum formulation according to claim 1, wherein at least 60% by weight, of the tobacco fibres are retained in the gum base about 10 minutes from initiation of a chewing process.

13. Chewing gum formulation according to claim 1, wherein more than 25% of the nicotine content in the chewing gum formulation is released from the chewing gum formulation within the first 5 minutes from initiation of a chewing process.

14. Chewing gum formulation according to claim 1, wherein more than 75% of the nicotine content in the chewing gum formulation is released from the chewing gum formulation within the first 10 minutes from initiation of a chewing process.

15. Chewing gum formulation according to claim 1, wherein the gum base comprises elastomer in the range of 5-40% by weight of the gum base, natural resin in the range of 8-45% by weight of the gum base, and synthetic resin in the range of 5-50% by weight of the gum base.

16. Chewing gum formulation according to claim 1, wherein the chewing gum formulation comprises gum base in an amount of 30 to 70% by weight of the chewing gum formulation.

17. Chewing gum formulation according to claim 1, wherein the chewing gum formulation comprises filler in an amount of 0.1 to 50% by weight of the chewing gum, wherein the filler is hydrophobic and wherein at least 90% of the filler is contained in the chewing gum throughout the chewing of a user during a chewing period of at least 10 minutes.

18. Chewing gum formulation according to claim 1, wherein the chewing gum formulation comprises filler in an amount of 0.1 to 50% by weight of the chewing gum and wherein the filler comprises magnesium and calcium carbonate, sodium sulphate, ground limestone, silicate compounds, kaolin and clay, aluminum oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, cellulose polymers and combinations thereof.

19. Chewing gum formulation comprising tobacco particles and a gum base, wherein the tobacco particles have a nicotine content and comprises tobacco fibers, and wherein the gum base comprises one or more hydrophobic gum base polymers, and wherein the tobacco particles are made from tobacco leaves, wherein the amount of tobacco particles is between 0.5 and 30% by weight of the chewing gum formulation, wherein at least 40% by weight of tobacco fibres comprised in the tobacco particles are retained in the chewing gum formulation after the chewing gum formulation has been chewed in vitro in accordance with European Pharmacopeia 6th. ed. 2.9.25 in a pH 7.4 phosphate buffer for 10 minutes, and wherein more than 40% of the nicotine content in the chewing gum formulation is released from the chewing gum formulation, after the chewing gum formulation has been chewed in vitro in accordance with European Pharmacopeia 6th. ed. 2.9.25 in a pH 7.4 phosphate buffer for 10 minutes.

20. Chewing gum formulation comprising tobacco particles and a gum base, wherein the tobacco particles have a nicotine content and comprises tobacco fibers, and wherein the gum base comprises one or more hydrophobic gum base polymers, and wherein the tobacco particles are made from tobacco leaves, wherein the amount of tobacco particles is between 0.5 and 30% by weight of the chewing gum formulation, wherein at least 30% by weight of tobacco fibres comprised in the tobacco particles are retained in the chewing gum formulation after the chewing gum formulation has been chewed in vitro in accordance with European Pharmacopeia 6th. ed. 2.9.25 in a pH 7.4 phosphate buffer for 10 minutes, and wherein more than 40% of the nicotine content in the chewing gum formulation is released from the chewing gum formulation, after the chewing gum has been chewed in vitro in accordance with European Pharmacopeia 6th. ed. 2.9.25 in a pH 7.4 phosphate buffer for 10 minutes.

Description

DETAILED DESCRIPTION OF THE INVENTION

(1) By the terms gum base and gum base matrix we mean the mainly water insoluble and hydrophobic gum base ingredients that are mixed together before the bulk portion of the chewing gum formulation is added.

(2) The term bulk portion intends to mean the mainly water soluble chewing and hydrophilic gum ingredients that are mixed into the gum base matrix after it has been mixed.

(3) The term weight of the chewing gum formulation or similar wording meaning the same is defined in the present context as weight of the chewing gum formulation, without including the weight of an outer coating, such as a hard coating, soft coating, and the like.

(4) By the phrase chewing gum is meant any chewing gum such as extruded chewing gum, centre-filled chewing gum, toffee-imitating chewing gum, compressed chewing gum, slabs or sticks.

(5) By the phrase texture is meant a qualitative measure of the visco-elastic properties of the chewing gum and of the overall mouth-feel experienced by the user during the chewing process. Thus the term texture encompasses measurable quantities such as hardness and elasticity as well as more subjective parameters related to the chew-feel experienced by a user.

(6) By the phrase retained is meant that e.g. fibres of tobacco powder are contained within the gum base of the chewing gum formulation after it has been chewed.

(7) The phrase hydrophobic is used to describe the ability of a substance to dissolve in or blend with apolar substances such as e.g. oils.

(8) The phrase hydrophilic is used to describe the ability of a substance to dissolve in or blend with polar substances, such as e.g. water.

(9) By the phrase tobacco particles is meant small parts made from tobacco leaves by conventional techniques.

(10) According to embodiments of the invention, the gum base matrix may constitute 50 to 80% by weight of the chewing gum formulation. The amount of gum base may in some embodiments constitute 60 to 70% by weight of the chewing gum formulation. According to other embodiments of the invention, the gum base matrix may constitute 20 to 50% by weight of the chewing gum formulation. The amount of gum base may in some embodiments constitute 30 to 40% by weight of the chewing gum formulation.

(11) In some embodiments of the invention, a buffer is added, the buffer being selected from the group consisting of a tris buffers, amino acid buffers, carbonate, including monocarbonate, bicarbonate or sesquicarbonate, glycerinate, phosphate, glycerophosphate, acetate, glyconate or citrate of an alkali metal, such as potassium and sodium, e.g. trisodium and tripotassium citrate, or ammonium, and mixtures thereof.

(12) When buffer is used, a preferred buffer is sodium bicarbonate. In some embodiments buffer is not part of the chewing gum formulation. In some other embodiments, buffer is part of the chewing gum formulation.

(13) In some embodiments of the invention, the amount of buffer is 0.5 to 10% by weight of the chewing gum formulation.

(14) In some embodiments of the invention the buffer is selected from the group consisting of a carbonate, including monocarbonate, bicarbonate or sesquicarbonate, glycerinate, phosphate, glycerophosphate, acetate, glyconate or citrate of an alkali metal, such as potassium and sodium, e.g. trisodium and tripotassium citrate, or ammonium, tris buffer, amino acids, and mixtures thereof.

(15) In some embodiments of the invention the buffer is selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono--lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, Sodium orthophosphate, Potassium orthophosphate, Calcium orthophosphate, Sodium diphosphate, Potassium diphosphate, Calcium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, Carbonic acid, Sodium carbonate, Sodium bicarbonate, Potassium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.

(16) The buffer may to some extent be microencapsulated or otherwise coated as granules with polymers and/or lipids being less soluble in saliva than is the one or more buffering agents. Such microencapsulation controls the dissolution rate whereby is extended the time frame of the buffering effect.

(17) However, in a presently preferred embodiment an alkaline buffer is preferred, such as sodium carbonate.

(18) According to the invention the presence of buffer allows in synergy with tobacco particles in the chewing gum formulation to adjust the release of nicotine from the tobacco particles and the bioavailability of the released nicotine in the oral cavity.

(19) According to the invention a preferred amount of gum base matrix in the final chewing gum is above 30 percent by weight of the chewing gum core, such as above 35 percent by weight of the chewing gum core, such as above 40 percent by weight of the chewing gum core, such as above 45 percent by weight of the chewing gum core, such as about 40 percent by weight of the chewing gum core, such as about 47 percent by weight of the chewing gum core.

(20) The formulation of gum base formulations can vary substantially depending on the particular product to be prepared and on the desired masticatory and other sensory characteristics of the final product. However, typical ranges (% by weight) of the above gum base components are: 5 to 80% by weight elastomeric compounds, 5 to 80% by weight elastomer plasticizers, 0 to 40% by weight of waxes, 5 to 35% by weight softener, 0 to 50% by weight filler, and 0 to 5% by weight of miscellaneous ingredients such as antioxidants, colourants, etc. The gum base may comprise about 5 to about 95 percent, by weight, of the chewing gum, more commonly the gum base comprises 10 to about 60 percent, by weight, of the gum.

(21) Elastomers provide the rubbery, cohesive nature to the gum, which varies depending on this ingredient's chemical structure and how it may be compounded with other ingredients. Elastomers suitable for use in the gum base and gum of the present invention may include natural or synthetic types.

(22) Elastomer plasticizers vary the firmness of the gum base. Their specificity on elastomer inter-molecular chain breaking (plasticizing) along with their varying softening points cause varying degrees of finished gum firmness and compatibility when used in base. This may be important when one wants to provide more elastomeric chain exposure to the alkane chains of the waxes.

(23) The elastomers (rubbers) employed in the gum base may vary depending upon various factors such as the type of gum base desired, the texture of gum formulation desired and the other components used in the formulation to make the final chewing gum product. The elastomer may be any water-insoluble polymer known in the art, and includes those gum polymers utilized for chewing gums and bubble gums. Illustrative examples of suitable polymers in gum bases include both natural and synthetic elastomers. For example, those polymers which are suitable in gum base formulations include, without limitation, natural substances (of vegetable origin) such as chicle gum, natural rubber, crown gum, nispero, rosidinha, jelutong, perillo, niger gutta, tunu, balata, guttapercha, lechi capsi, sorva, gutta kay, and the like, and mixtures thereof. Examples of synthetic elastomers include, without limitation, styrene-butadiene copolymers (SBR), polyisobutylene, isobutylene-isoprene copolymers, polyethylene, polyvinyl acetate and the like, and mixtures thereof.

(24) In some embodiments of the present invention tobacco powder is added to the gum base together with other gum base ingredients.

(25) Natural resins may be used according to the invention and may be natural rosin esters, often referred to as ester gums including as examples glycerol esters of partially hydrogenated rosins, glycerol esters of polymerised rosins, glycerol esters of partially dimerized rosins, glycerol esters of tally oil rosins, pentaerythritol esters of partially hydrogenated rosins, methyl esters of rosins, partially hydrogenated methyl esters of rosins, pentaerythritol esters of rosins, synthetic resins such as terpene resins derived from alpha-pinene, beta-pinene, and/or d-limonene, and natural terpene resins.

(26) In an embodiment of the invention, the resin comprises terpene resins, e.g. derived from alpha-pinene, beta-pinene, and/or d-limonene, natural terpene resins, glycerol esters of gum rosins, tall oil rosins, wood rosins or other derivatives thereof such as glycerol esters of partially hydrogenated rosins, glycerol esters of polymerized rosins, glycerol esters of partially dimerised rosins, pentaerythritol esters of partially hydrogenated rosins, methyl esters of rosins, partially hydrogenated methyl esters of rosins or pentaerythritol esters of rosins and combinations thereof.

(27) In an embodiment of the invention, said chewing gum ingredients are selected from the group consisting of bulk sweeteners, flavors, dry-binders, tabletting aids, anti-caking agents, emulsifiers, antioxidants, enhancers, absorption enhancers, buffers, high intensity sweeteners, softeners, colors, or any combination thereof.

(28) The tobacco particles may in some embodiments of the invention be added to the chewing gum as a part of the bulk portion together with the other chewing gum ingredients.

(29) In an embodiment of the invention, the chewing gum formulation comprises sweeteners, such as bulk sweeteners, sugar sweeteners, sugar substitute sweeteners, artificial sweeteners, high-intensity sweeteners, or any combination thereof.

(30) Suitable bulk sweeteners include both sugar and non-sugar sweetening components. Bulk sweeteners typically constitute from about 5 to about 95% by weight of the chewing gum, more typically about 20 to about 80% by weight such as 30 to 70% or 30 to 60% by weight of the gum.

(31) Useful sugar sweeteners are saccharide-containing components commonly known in the chewing gum art including, but not limited to, sucrose, dextrose, maltose, dextrins, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, and the like, alone or in combination.

(32) Sorbitol can be used as a non-sugar sweetener. Other useful non-sugar sweeteners include, but are not limited to, other sugar alcohols such as mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, isomalt, erythritol, lactitol and the like, alone or in combination.

(33) High intensity artificial sweetening agents can also be used alone or in combination with the above sweeteners. Preferred high intensity sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, sterioside and the like, alone or in combination. In order to provide longer lasting sweetness and flavor perception, it may be desirable to encapsulate or otherwise control the release of at least a portion of the artificial sweeteners. Techniques such as wet granulation, wax granulation, spray drying, spray chilling, fluid bed coating, conservation, encapsulation in yeast cells and fiber extrusion may be used to achieve desired release characteristics. Encapsulation of sweetening agents can also be provided using another chewing gum component such as a resinous compound.

(34) Usage level of the artificial sweetener will vary considerably and will depend on factors such as potency of the sweetener, rate of release, desired sweetness of the product, level and type of flavor used and cost considerations. Thus, the active level of artificial sweetener may vary from about 0.001 to about 8% by weight (preferably from about 0.02 to about 8% by weight). When carriers used for encapsulation are included, the usage level of the encapsulated sweetener will be proportionately higher. Combinations of sugar and/or non-sugar sweeteners may be used in the chewing gum formulation.

(35) A chewing gum base formulation may, if desired, include one or more fillers/texturisers including as examples, magnesium and calcium carbonate, sodium sulphate, ground limestone, silicate compounds such as magnesium and aluminum silicate, kaolin and clay, aluminum oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, cellulose polymers, such as wood, and combinations thereof.

(36) A number of chewing gum components well known within the art may be applied within the scope of the present invention. Such components comprise but are not limited to waxes, fats, softeners, fillers, flavors, anti-oxidants, emulsifiers, colouring agents, binding agents and acidulants

(37) In an embodiment of the invention, the chewing gum formulation is provided with an outer coating.

(38) In an embodiment of the invention, said outer coating is selected from the group consisting of hard coating, soft coating and edible film-coating or any combination thereof.

(39) The following non-limiting examples illustrate different variations of the present invention. The examples are meant for indicating the inventive concept; hence the mentioned examples should not be understood as exhaustive for the present invention.

EXAMPLES

Example 1Preparation of Gum Base without Tobacco Particles

(40) The composition of a gum base is presented in Table 1.

(41) TABLE-US-00001 TABLE 1 Gum base composition. Amounts are given in wt- % of the gum base. GB std. Elastomer 16.0 Resins 44.5 Filler 15.0 Plasticizers 24.4 Antioxidant 0.1 GB = Gum Base.

(42) The preparation of gum base is carried out by first adding a high-molecular weight elastomer, synthetic resin and filler to a heated (about 120 C.) and running z-blade mixer. After about twenty minutes of mixing, natural resin is added to the running mixer and mixing is continued for about five minutes followed by addition of further natural resin. After about five minutes of continued mixing, some plasticizer and further elastomer are added to the running mixer, and mixing is continued for about five minutes before addition of further plasticizer and antioxidant to the running mixer. Mixing is continued for about half an hour to one hour, and the final gum base mass is emptied from the mixer into coated or lined pans, extruded or cast into any desirable shape. Those skilled in the art will recognize that many variations of the above-described procedure may be followed.

Example 2Preparation of Chewing Gum

(43) In the present example, the gum base standard from example 1 GB std. was made into chewing gum CG std. with the composition as described in Table 2.

(44) TABLE-US-00002 TABLE 2 Amounts are given in % by weight of the chewing gum formulation. CG std. GB std. 42 Tobacco particles 5 Bulk Sweetener 50.3 Sorbitol Tobacco flavour 2 Intense sweeteners 0.7 CG = Chewing Gum

(45) A conventional mechanical mixing procedure is used. The gum base is added to a mixing kettle provided with mixing means like e.g. horizontally placed Z-shaped arms. The kettle had been preheated to a temperature of up to approximately 50 C., and the other ingredients are added according to a specified time schedule. Obviously, the amount of ingredients used may be varied within the scope of the present invention.

(46) The chewing gum formulation may optionally be coated by means of hard coating. The coating may e.g. be applied according to conventional coating methods. The pieces evaluated are without coating

Example 3Preparation of Chewing Gum with Tobacco Particles, Size/Amount

(47) Chewing gums comprising varying sizes and amounts of tobacco particles were made according to various embodiments of the present invention.

(48) The chewing gum of example 2 was used with tobacco particles with tobacco amount and size as indicated in Table 3 replacing the corresponding amount of bulk sweetener. The resulting chewing gums are in Table 3 named for later reference.

(49) TABLE-US-00003 TABLE 3 Avg. size is the average maximum dimension of the tobacco particles and the amount of tobacco is given in % by weight of the chewing gum Avg. size (m) Tobacco (wt-%) 40 250 500 750 2500 1 CG01 CG06 CG11 CG16 CG21 5 CG02 CG07 CG12 CG17 CG22 10 CG03 CG08 CG13 CG18 CG23 20 CG04 CG09 CG14 CG19 CG24 30 CG05 CG10 CG15 CG20 CG25

(50) The chewing gum with lower tobacco content (1-5 wt-%) had a mild taste of tobacco while with higher tobacco content (10-30 wt-%) had a distinct and pleasant tobacco taste.

Example 4Preparation of Chewing Gum with Tobacco Particles, Nicotine Content

(51) Chewing gums comprising tobacco particles with varying nicotine content were made according to various embodiments of the present invention. The varying nicotine content may be obtained by using either low- and/or high-nicotine containing types of tobacco in any combination. Hereby a desired nicotine content in the tobacco particles to be used may be obtained as seen in Table 4 below.

(52) The chewing gum of example 2 was used with different types of tobacco particles replacing the corresponding amount of bulk sweetener, which contained amounts of nicotine as indicated in Table 4. The resulting chewing gums are in Table 4 named for later reference.

(53) TABLE-US-00004 TABLE 4 The amount of tobacco is given in % by weight of the chewing gum and the amount of nicotine is given in % by weight of the tobacco. Tobacco (wt- %) Nicotine (wt- %) 1 5 10 20 30 0.3 CG26 CG31 CG36 CG41 CG46 0.7 CG27 CG32 CG37 CG42 CG47 1.7 CG28 CG33 CG38 CG43 CG48 3.4 CG29 CG34 CG39 CG44 CG49 8.4 CG30 CG35 CG40 CG45 CG50
Surprisingly, the chewing gums with highest nicotine content still had a pleasant taste and texture.

Example 5Preparation of Chewing Gum with Tobacco Particles, Moisture Content

(54) Chewing gums comprising tobacco particles with varying moisture content were made according to various embodiments of the present invention. The varying moisture content may be obtained by drying or adding extra water to any type of tobacco before adding it to the chewing gum. Hereby a desired moisture content in the tobacco particles to be used may be obtained as seen in Table 5 below.

(55) The chewing gum of example 2 was used with tobacco particles, which had a moisture content as indicated in Table 5, replacing the corresponding amount of bulk sweetener. The resulting chewing gums are in Table 5 named for later reference.

(56) TABLE-US-00005 TABLE 5 The amount of tobacco is given in % by weight of the chewing gum and the moisture content is given in % by weight of the tobacco. Tobacco (wt- %) Moisture (wt- %) 1 5 10 20 30 2 CG51 CG56 CG61 CG66 CG71 5 CG52 CG57 CG62 CG67 CG72 11 CG53 CG58 CG63 CG68 CG73 18 CG54 CG59 CG64 CG69 CG74 26 CG55 CG60 CG65 CG70 CG75
Surprisingly, the moisture content of the tobacco particles may be varied without compromising taste and texture of the chewing gum.

Example 6Preparation of Chewing Gum with Tobacco Particles, Buffer

(57) Chewing gums comprising tobacco particles with varying sizes were combined with various amounts of buffer according to various embodiments of the present invention.

(58) The chewing gum of example 2 was used with buffer in amounts as indicated in Table 6 and tobacco particles in an amount of 5% of the chewing gum replacing the corresponding amount of bulk sweetener. The buffer used was a 50/50 by weight of NaHCO.sub.3 and Na.sub.2CO.sub.3. The resulting chewing gums are in Table 5 named for later reference.

(59) TABLE-US-00006 TABLE 6 The nicotine content is given in % by weight of the tobacco particles and the buffer content is given in % by weight of the chewing gum Nicotine (wt- %) Buffer (wt- %) 0.7 2.4 4.3 0 CG76 CG81 CG86 0.5 CG77 CG82 CG87 3 CG78 CG83 CG88 6 CG79 CG84 CG89 8 CG80 CG85 CG90

Example 7Preparation of Chewing Gum with Tobacco Particles, GB-Ingredients

(60) Chewing gums with tobacco particles in combination with varying gum base ingredients were made according to various embodiments of the present invention. The resulting gum bases were made into chewing gums in accordance with the description in example 2. The resulting chewing gums are in Table 7 named for later reference.

(61) TABLE-US-00007 TABLE 7 The content of the individual ingredients are given in % by weight of the gum base. CG91 CG92 CG93 CG94 CG95 CG96 CG97 Elastomer 16.0 17.5 10.0 16.0 13.0 19.0 15.0 Resins 44.5 48.0 49.7 40 37.5 26.5 32.5 Filler 1.0 2.5 2.6 6.5 11.0 16.0 4.0 Plasticizers 24.4 18 23.6 23.5 24.4 24.4 34.4 Antioxidant 0.1 0.05 0.1 0.0 0.1 0.1 0.1 Tobacco 14 14 14 14 14 14 14

Example 8In Vitro Release of Nicotine

(62) The release rate of nicotine from CG14 in Example 3 with tobacco particles with app. 11% moisture content and 2-3% nicotine, was measured according to the procedure set forth in the Ph. Eur. 6.sup.th ed. 2.9.25, at pH=7.4, a chewing rate of 60 chew per minute, and with the temperature of the medium at 37 C. With the same setting, the release rate from three prior art pieces, PA1, PA3, PA4, of nicotine gum was measured for comparison. The release rate can be seen in Table 8.

(63) TABLE-US-00008 TABLE 8 the time given is from initiation of a chewing process as described and the values given are % by weight of the total content of nicotine in the products CG14 PA4 CG98 PA1 PA3 Time (Wt- %) (Wt- %) (Wt- %) (Wt- %) (Wt- %) 5 min 61 51 83 45 15 10 min 85 72 91 66 36 20 min 89 92 95 83 56 30 min 90 95 97 90 70

(64) The results clearly show a significantly faster release of nicotine from the tobacco chewing gum formulation according to an embodiment of the present invention as compared to conventional nicotine gum.

(65) A number of further measurements were carried out with other chewing gums with varying contents of tobacco particles, elastomers, resins and buffer were tested and showed in general an improved faster release of nicotine as compared to conventional chewing gum.

(66) It is noted that the CG14 and PA4 are directly comparable and both have the same gum base composition and gum base content.

(67) The gum base content and gum base composition is also the same for CG98 and PA1 but differs from CG14 and PA4.

(68) The chewing gum composition of PA3 is unknown but refers to a Nicorette nicotine chewing gum where nicotine is contained in the form of a nicotine polacrilex resin (NPR), as is also the case for PA1 and PA4.

Example 9In Vitro Release, Retention of Fibres of Tobacco Particles

(69) The retention of the fibres of tobacco particles in the gum base upon chewing gum was investigated by carrying out the procedure set forth in the Ph. Eur. 6.sup.th ed. 2.9.25, at pH=7.4, a chewing rate of 60 chew per minute, and with the temperature of the medium at 37 C.

(70) The chewing time was 10 minutes.

(71) The buffer from the chewing process was collected and filtered through weighed filter paper (pore size 5-10 micrometer) and dried in an oven at 50 C. until dry.

(72) CG99 was a extruded chewing gum pellet comprising tobacco powder corresponding to a nicotine content of 2% by weight of the pellet.

(73) CG100 was a 2 layer compressed chewing gum tablet with tobacco powder in one layer corresponding to a nicotine content of 2% by weight of the tablet.

(74) CG102 was an extruded chewing gum pellet comprising no tobacco powder and thus represents a blind.

(75) TABLE-US-00009 TABLE 9 Release of tobacco fibers from chewing gum tablets and chewing gum pellets compared to a blind. Fibers Dried retained Release Initial filter Fibers on the of fibers amount paper retained filter (>10 m) tobacco Filter with on the corrected from powder paper fibers filter for blind chewing Product mg Mg mg mg mg gum %) CG99 127 547 558.4 11.4 17.8 35 CG100 97.6 546.7 571.5 24.8 31.2 80 CG102 0 537.6 531.2 6.4 0 0

(76) The chewing gums CG 99 and CG 100 were made from the below gum bases GB 99 and GB 100 and the applied tobacco powder was added to the chewing gum composition.

(77) TABLE-US-00010 GB99 GB100 Elastomer 14 20 Resins 40 37 Filler 21 19 Plasticizers 24.9 23.95 Antioxidant 0.1 0.05
The chewing gum compositions were:

(78) TABLE-US-00011 CG99 CG100 GB99 40 GB100 42 Tobacco particles 12.7 6.1 Bulk Sweetener 38 46 Flavour 2.5 2.35 Intense sweeteners 1.8 1.25 Buffer and softener 5.0 2.3
Table 9 shows that about 35% of tobacco fibers are released in an extruded chewing gum pellet (CG 99),

(79) It should be noted that the retention of tobacco particles refer to the fibre content as initial content of e.g. humidity or other compounds, in particular hydrophilic compounds in the tobacco powder will at least to some extend be released during chewing. In the present context, measurements have shown that the applied tobacco particles contains about 60% hydrophilic components and about 40% fibres.

(80) It should also be noted that CG100 shows a relatively high release of tobacco fibers. In this context, it should be noted that compressed chewing gum release nicotine even faster than CG99 which is a conventional mixed chewing gum. Hence, the relative release of fibres is also less than the release of nicotine in CG100.

(81) It has been shown that fibres of tobacco particles showed retention in the gum base and only moderate transferring of the tobacco fibre content of the tobacco particles into the saliva occurs when using a mixed chewing gum even in spite of the fact that the nicotine releases faster.

(82) Other visual tests performed on extruded or batch mixed chewing gums indicated that fibre content of the tobacco powder is retained to a large degree in spite of the fact that the chewing gum tested all showed increased release of nicotine compared to conventional nicotine chewing gum, where the nicotine is contained in e.g. NPR. In other words, there were clear indications that the chewing gums according to the provisions of the invention were able to retain substantial amounts of the tobacco fibres and release the nicotine contained in the tobacco powder.

Example 10Preparation of Gum Base with Tobacco Particles

(83) The composition of a further gum base is presented in Table 10.

(84) TABLE-US-00012 TABLE 10 Gum base composition. Amounts are given in wt-% of the gum base. GB std. Elastomer 16.0 Resins 44.5 Filler 5.0 Tobacco particles 10.0 Plasticizers 24.4 Antioxidant 0.1 GB = Gum Base.

(85) As compared to the gum base of example 1, tobacco particles are included in the gum base. This gum base is further made into a chewing gum as described in example 2, only without the tobacco particles. However, obviously a combination of tobacco particles inside and outside a gum base may be used as well within the scope of the present invention.